Memorandum by Dr Charles Kent (NC 55)
1.1 Specific concerns have been raised by
local general practitioners following the publication of a number
of NICE guidance documents and the recent change to the National
Health Service Act 1977 making implementation of NICE guidance
mandatory within a limited timescale. These concerns are outlined
in the following submission of written evidence. In the interest
of brevity, examples have been kept concise however a more detailed
account of the specific concerns is attached (appendix 1) and
can be expanded further upon request.
1.2 This submission is sent on behalf of
the Mid Devon Doctor's Group. This is a group of approximately
70 GPs and includes all GPs in Mid Devon PCT where there has been
a culture of collaborative working for some time.
2.1 Guidance has been found to be less informative
when considering a drug for which there other established treatment
options available (zanamivir vs. simple analgesia, rest and fluidsCox-II
inhibitors vs "lower risk" traditional agent with gastroprotection)
or when drug therapy forms part of an overall strategy (sibutramine
2.2 The credibility of some guidance has
been questioned in terms of their clinical and cost-effectiveness
(see paragraph 5). The Mid Devon Doctor's group also became very
concerned in the autumn of 2000 by the decision of NICE to reverse
its previous recommendation with regards the use of zanamivir.
Guidance appeared to ignore an increasing body of International
concern about how zanamivir should be used, particularly in patients
with asthma and COPD, and was in conflict with the current Summary
of Characteristics (SPC). For these reasons, it was considered
inappropriate locally to issue this black triangle drug via a
patient group direction. Zanamivir was recommended with the potential
to increase inappropriate consultation rates, despite recognising
that diagnostic ability was limited. There was also unease that
a large proportion of the evidence considered was unpublished.
Several invitations were given inviting Professor Sir Michael
Rawlins to debate the issues raised by the Mid Devon Group, sadly
this never occurred.
3. HAS ENDED
3.1 No. The relationship between NICE guidance/clinical
guidelines and National Service Frameworks (with subsequent local
treatment targets or guidelines) is unclear.
4.1 It is widely accepted that ownership
of guidelines is highest in those who have been involved in the
development of such guidance. Whilst it is recognised that national
guidance is a sensible approach to avoid duplication of effort,
some loss of local ownership is inevitable.
5. IS ACTIVELY
5.1 Zanamivir to treat influenzaTrial
data primarily considered one group of "at risk" patients
and the majority of patients receiving the drug were of a different
age range to the group that NICE identified as being at high risk.
It was unclear if the results could be translated into general
practice due to differences in prevalence of influenza in the
trial population, lower vaccination rates and time to presentation.
The overall reduction in duration of symptoms was small and the
reduction in use of antibiotics (of borderline significance) was
seen as an inappropriate indicator for assuming a reduction in
hospital admissions and death.
5.2 Orlistat and sibutramine in the treatment
of obesityAlthough trials showed statistically significant
differences in weight loss compared to placebo, the mean differences
between treatment groups were sometimes small and therefore may
not be clinically significant. Both drugs have not been shown
to be effective and safe in the longer-term. Weight loss following
cessation of therapy is usually regained over time and therefore
the use of anti-obesity drugs may detract from patients making
long-term healthy lifestyle changes. Sibutramine is considered
complicated to prescribe.
5.3 In terms of cost-effectiveness of guidance
issued, it is recognised that pharmacoeconomic analysis is a relatively
new science and is only as robust as the data included. Much of
the evidence on cost-effectiveness of newer interventions remains
inconclusive due to insufficient information and therefore it
is recommended that these data models be viewed with caution.
Despite this, the Institute has issued guidance that requires
vast sums of investment for drugs where the cost-effectiveness
of such interventions is uncertain (riluzole, zanamivir, drugs
to treat Alzheimer's disease).
6.1 It is unclear from the guidance documents
whether Appraisal Committee members have interests to declare
and, if they do, there is no indication as to how the Institute
deal with these potential conflicts of interest or if the individual
is distanced from the appraisal process in any way.
7.1 In an environment where there are numerous
policy documents with limited funding available, it is necessary
to "prioritise the priorities". Inevitably this will
result in a postcode service provision through either the decision
not to fund a drug therapy or the need to suspend services in
order to fund an overspend. Locally, the latter is currently the
case. If national policy (NICE and NSFs) continues to be issued
with targets for implementation then this must be reflected by
realistic budgetary uplift to the unified allocation. There is
also the potential to divert funds from other technologies with
a sound evidence-base and improved health gain but which are not
to be reviewed by NICE and are effectively not a "must do".
Dr Charles Kent
General Practitioner and Chair of the Mid Devon Doctor's
Threshers, Crediton EX17 3JJ.
Telephone(01363) 772227, Fax(01363)